300 micron laser fiber (KTP) 11637

GUDID 00810077631355

General/multiple surgical laser system beam guide, single-use

Primary Device ID	00810077631355
NIH Device Record Key	7bd3d8b7-63ba-4a75-a6bb-2d7be305ba1f
Commercial Distribution Status	In Commercial Distribution
Brand Name	300 micron laser fiber (KTP)
Version Model Number	11637
Catalog Number	11637
Company DUNS	024050887
Company Name	OPTICAL INTEGRITY INC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 37 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00810077631355 [Primary]

GEX	Powered Laser Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	true

00810077631355	300 micron laser fiber, single use disposable (KTP)
00810077631362	300-micron laser fiber, single use disposable (KTP)